BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    SSC8 SORENSON SUBCLAVIAN CATHETER

    K Number: K801478 · Decision Aug 27, 1980
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    22
    Applicant Total
    69
    Review Days
    64

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    Basic Information

    Device Name
    SSC8 SORENSON SUBCLAVIAN CATHETER
    K Number
    K801478
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    876.5540
    Medical Specialty
    Gastroenterology, Urology
    Decision
    Substantially Equivalent
    Applicant
    Sorensen Research
    Date Received
    June 24, 1980
    Decision Date
    August 27, 1980
    Product Code
    FIQ
    Advisory Committee
    Gastroenterology, Urology
    Review Advisory Committee
    GU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    FIQ Cannula, A-V Shunt

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